Final report of an audit conducted in the United States of America to evaluate the food safety systems governing the production of meat and poultry products intended for export to Canada – January 23^rd to February 10^th, 2017

Abbreviations and special terms used in the report

AMR:

Advanced meat recovery

AMS:

USDA agricultural marketing service

APHIS:

Animal and plant health inspection service

BSE:

Bovine spongiform encephalopathy

CCA:

Central competent authority

CI:

On-line carcass inspector

CFIA:

Canadian food inspection agency

CSI:

Consumer safety inspector

DDM:

Deputy district manager

DM:

District manager

D.O.:

District office

DOA:

Dead on arrival

DRG:

Dorsal root ganglia

DVMS:

District veterinary medical specialist

FLS:

Front line supervisor

FMIA:

Federal meat inspection act

FSA:

Food safety assessment

FSIS:

Food safety inspection service

GCP:

Good commercial practices

HATS:

Humane activities tracking system

HIMP:

HACCP-based inspection model project

I Establishment:

Official import establishment where FSIS perform import inspection under Federal Meat Inspection Act (FMIA), Poultry Product Inspection Act (PPIA), Egg Production Inspection Act (EPIA).

IIC:

Inspector in charge (veterinarian in charge)

IPP:

Inspection program personnel

IPPS:

In-plant performance system

LOC:

Letter of concern

M establishment:

Official establishment where FSIS inspect meat and meat products under Federal Meat Inspection Act (FMIA).

MOI:

Memorandum of interview

NR:

Non-compliance record

NC:

Non compliance

NELS:

New line speed inspection system

NOIE:

Notice of intended enforcement

NPIS:

New poultry inspection system

P establishment:

Official establishment where FSIS inspect poultry and poultry products under PPIA

PPIA:

Poultry Products Inspection Act

PHIS:

Public health information system

PHR:

Public health risk

PHRE:

Public health risk evaluation

RTE:

Read to eat

SIP:

Salmonella initiative program

SRM:

Specific risk material

SOP:

Standard operating procedures

SSOP:

Sanitation standard operating procedures

STAR:

Supervisory tool for assessment results

USDA:

United States department of agriculture

V establishment:

Voluntary inspection facility where FSIS perform some kind of voluntary inspection (usually under authority of AMA).

Executive summary

This report describes the outcome of an on-site audit assessment of the food safety systems in the United States of America (USA; hereafter referred as US) governing the production of meat and meat products intended for export to Canada that was conducted by the Canadian Food Inspection Agency from January 23 to February 10, 2017. Overall, the audit showed that food safety systems in the US are performing as intended in an adequate manner and generally demonstrate an acceptable implementation of controls for all areas described above. Based on the audit findings, recommendations are made with the intent of finding solutions for identified deficiencies.

The main objective of the audit was to verify that the food safety systems governing meat products in the US are functioning in a manner determined to be equivalent to that of Canada producing meat products that are safe, unadulterated, and properly labelled. The scope of assessment focused on verification of activities within the following subject areas:

• competent authority and oversight
• ante-mortem, humane handling and animal welfare controls
• slaughter and post-mortem
• processing controls
• hazard analysis and critical control points plan and pre-requisite programs controls
• microbiological controls

1 Introduction

The Canadian Food Inspection Agency (CFIA) conducted an audit of the US meat and meat products food safety system from January 23 through February 10, 2017. The CFIA selected official establishments with M and/or P designation as well as establishments with a V or I designation, which were eligible to export meat and/or meat products to Canada. The audit findings pertaining to inspection oversight at the establishments were discussed at the end of each audit day with the local Food Safety Inspection Service (FSIS) inspection personnel.

1.1 Audit objective, scope, and methodology

In preparation for this audit, the CFIA used a risk-based procedure to determine the audit scope, which included an analysis of production types and volumes, recalls and port of entry violations.

The CFIA auditors were accompanied throughout the audit by representatives from the CCA (Central competent authority). Program effectiveness determination focused on the government controls and oversight within 6 areas of risk:

• competent authority and oversight
• ante-mortem, humane handling and animal welfare controls
• post-mortem and slaughter
• processing controls
• hazard analysis and critical control points (HACCP) plan and prerequisite programs controls
• microbiological controls

Administrative functions were reviewed at CCA headquarters and 1 district office, during which the auditors evaluated that inspection, verification, and enforcement procedures were being implemented as intended. 18 establishments were selected from the list of United States department of agriculture (USDA) establishments that were eligible to export meat and poultry products to Canada at the time of the audit.

The CFIA auditors verified the system and its implementation via:

• FSIS presentations
• USDA inspection laws granted in the federal Meat Inspection Act and Regulations
• FSIS directives and verification inspection tasks
• on-site visit interviews with inspection personnel and operator at the establishments
• consultation of the PHIS (Public health information system) web based program and AG learn
• In the establishments visited, audit team consulted
  • HACCP plan, pre-requisite programs and standard operating procedure (SOP)
  • policies, procedures, formulations, validations and sampling plan
  • animal welfare programs

1.2 Legal basis for the audit and audit standards

The audit was undertaken under the specific provisions of Canadian laws and regulations, in particular:

• the Meat Inspection Act; and
• the Meat Inspection Regulations 1990

The audit was conducted in a manner consistent with conventional program delivery audit standards, and was intended to assess the degree to which inspection activities performed by the CCA were consistent with the regulatory and procedural requirements and specifications.

1.3 Background

The US is eligible to export raw and processed red meat and poultry products to Canada. Between January and December 31 2016, the US exported approximately 217 million kilograms of poultry meat and meat products and 302 million kilograms of red meat and meat products to Canada.

The CFIA had performed an audit of the US' meat and poultry inspection system in 2013. Establishments audited included bovine/swine/poultry slaughter/processing establishments, meat/poultry processing establishments, microbiology laboratory and a district office.

2 Competent authority and oversight

Canadian import eligibility requirements indicate that the foreign inspection system shall be organized and administered by the government of the foreign country and must provide standards equivalent to those of the federal meat inspection system in Canada. For the United States, the authority to enforce USDA inspection laws is granted in the federal Meat Inspection Act and Regulations, and the Poultry Products Inspection Act and regulations. It is implemented through US Department of agriculture- food safety inspection service (USDA-FSIS) directives and notices.

The Inspection program personnel (IPP) are to use the PHIS task calendar to schedule their inspection tasks. The PHIS provides information about the appropriate tasks for each establishment, their relative priorities based on their expected impact on public health, and their expected frequencies. The PHIS program assigns inspection tasks based on information in the establishment profile. The office of policy and program development (OPPD) designs and maintains the tasks in the task library and the data analysis and integration Group (DAIG) sets task frequencies based on analysis of the relative public health importance of each task. The PHIS is designed on a risk-based inspection algorithm which combines an estimate of the inherent risk of the establishment (inherent risk measure) and an estimate of how well the establishment controls those potential risks (risk control measure).

2.1 Training

IPP is the largest category of employees in the FSIS; with over 7,500 nationwide. All new inspectors receive an orientation training covering administrative tasks, code of conduct and professionalism. IPP is responsible for the on-line inspection in the slaughterhouse and basic training includes in-class and on-site training, shadowing and mentoring which lasts for 12-18 months. The offline consumer safety inspector (CSI) ensures that the plant is operating within its written plans for HACCP, sanitation, and processing. The CSI receives additional training in class and on-site about HACCP, sanitation standard operating procedures (SSOP), Information technology (IT), humane handling, ready to eat (RTE), RTE processed product, raw and heat treated products, export, and sampling. Furthermore, CSI training includes shadowing and mentoring with colleagues and supervisors.

The training of a new veterinarian employee includes orientation, inspection techniques, pathology, dispositions, supervisory training and enforcement, humane handling of animals, sampling and residue. The training is complete upon approval by a mentor.

AG learn is the learning management system containing FSIS specific courses for inspection program personnel, and used to maintain training records of FSIS employees. All employees have access to web-based training via AG Learn.

2.2 Supervisory oversight

The U.S. states are divided into 10 district areas with a variable number of states to supervise. The district offices (office of field operation) are responsible for the supervisory oversight of inspection staff. The front line supervisor (FLS) is under the supervision of the deputy district managers (DDM) who report to the district manager (DM) at the district office (D.O.). FLS has work unit meetings and monthly conference calls with the district office. The communication between the various management levels is completed via on-site visits, internet and phone calls. The DDM supervises and correlate the work of their FLS twice a year.

The IPPS (in-plant performance system) is the mandatory and statutory tool that supervisors use to assess the performance of non-supervisory in-plant inspection program personnel such as on-line IPP, CSI and public health veterinarians. An IPPS review can be conducted by the office of field operations supervisors including FLS, multi-IPPS supervisors, supervisory public health veterinarians and supervisory consumer safety officers.

A minimum of 2 IPPS assessments should be conducted for each employee per fiscal year. 3 methods are used to assess the performance of the inspection program personnel: observation, records review, and discussion. These are documented in the IPPS assessment sheet.

The supervisory tool for assessment results (STAR) is a tool that supervisors use to assess the knowledge and proficiency of field level supervisory personnel. The STAR allows determining whether in-plant, subordinate supervisors carry out both program activities and supervisory responsibilities. The STAR is used for supervisory public health veterinarians (SPHVs), supervisory consumer safety inspectors (SCSI), and supervisory personnel stationed at HACCP- based inspection models project (HIMP) establishments. At least one, in-person assessment must be conducted and documented for each covered employee during the rating cycle.

2.3 Regulatory enforcement

The USDA-FSIS PHIS is a web-based inspection tool allowing inspection staff to manage inspection activities and their history, such as inspection tasks and their status; NR; FSAs; MOIs; appeals to NR; direct links to NR, food safety assessment (FSA) and memorandum of interview (MOI). The regulatory enforcement is done on-site by the IIC (inspector in charge) and CSI in the establishments M and P and by the CSI in the V and I establishments.

In a situation of non-compliance, the FSIS has regulatory authority to retain/reject product, stop a line and refuse to allow the processing of specifically identified products. As per 9 CFR 500.2, the reasons for which the FSIS may decide to take a regulatory control action includes: unsanitary conditions or practices, product adulteration or misbranding, conditions that preclude FSIS from determining that product is not adulterated, misbranded or inhumanely handled or during slaughter. 3 types of enforcement actions defined in the 9 CFR 500.1 is:

• regulatory control action: the retention of product, rejection of equipment or facilities, slowing or stopping of lines, or refusal to allow the processing of specifically identified product
• withholding action: the refusal to allow the application of marks to be applied to products. A withholding action may affect all product in the establishment or product produced by a particular process; and
• suspension: an interruption in the assignment of program employees to all or part of an establishment

In a situation of non-compliance observed at official establishments, FSIS inspectors follow pre-determined steps to escalate the issue(s)

• MOI: If the non-compliance poses no food safety issue, then it is recorded and followed-up through a MOI.
• NR: If the non-compliance poses a food safety risk, or when non-compliance is not addressed by the operator through the MOI, then it is documented and followed-up through a NR. Each month the Office of Data Integration and Food Protection (ODIFP) uses the results of inspection tasks to calculate Public Health Risk (PHR) non-compliance rate for each official meat and poultry establishments. IPP then compares the establishment's NR rate to 2 set cut points (for early warning and for PHRE/FSA scheduling). A PHR alert will be issued to CSI and IIC when an establishment has a non-compliance rate that is elevated and is at or exceed the Noncompliance Cut Point for Early Warning. If this rate reaches a rate that is higher than the cut point for PHRE/FSA scheduling, a PHRE is to be scheduled. The PHR alert is discussed with the FLS.
• D.O.: If the non-compliance is not appropriately addressed by the operator through a NR, the issue can be escalated to the D.O. establishments with a PHR NR rate that exceeds the noncompliance cut point for public health risk evaluation (PHRE)/food safety assessment (FSA) scheduling will be listed in the PHRE/FSA monthly schedule. The non-compliance is then assessed through a risk prioritization tool (PHRE) which will determine if a FSA or notice of intended enforcement (NOIE) will be performed. The D.O. can decide to pursue immediately an enforcement action under 9 CFR 500.3 and issues a notice of suspension (NOS) letter. When the D.O. decides to immediately pursue an enforcement action under 9 CFR 500.4, such as withholding action or suspension with prior notification, it issues a NOIE letter. In connection with these enforcement actions, the D.O. prepares an administrative enforcement report (AER) case file to include all applicable information related to an establishment.

At the time of the audit, it was explained to the auditors that an establishment is not required to respond in writing to a NR. When IPP document noncompliance, the establishment must comply with regulatory requirements by correcting the noncompliance. In some situations, the establishment response will include documenting the corrective actions in the establishment SSOP or HACCP records. Providing FSIS a written/documented response to the NR is voluntary on part of the establishment. However, the establishment is responsible for bringing itself back into compliance. There is no specified timeframe in the regulations for establishment to correct a noncompliance described in an NR. However, the establishment should immediately addresses issues related to product adulteration or the creation of unsanitary conditions. In order to close a NR, the inspector must verify onsite if the non-compliance is addressed in a satisfactory manner. The NR can only be closed after inspection program personnel have verified that the establishment has met the requirements of 9 CFR 416.15 and 417.3. PHIS do not allow the inspection task to be designated as "completed" until IPP have verified and documented that the establishment has brought itself into a state of compliance.

High numbers of open and closed NR were observed in various establishments audited, many of which were related to the same causeCFIA auditors were informed during an interview that a NR can be linked with other similar repetitive NR for the first 90 days of a NR being issued; thereafter it is not possible to link the NR. As described in FSIS Notice 13-16, the links between NR serve as a marker to the PHIS system and identify a loss of control of the process.

If the non-compliance is related to egregious inhumane handling, the NR can be escalated to the D.O. level where the case analysis (documentation and on-site evaluation) is conducted by district veterinary medical specialist (DVMS). An egregious situation is any act or condition that results in severe harm to animals as defined in the FSIS directive 6900.2. The analysis may results to a letter of concern (LOC), a letter of warning (LOW) or finally Letter of suspension (LOS) issued by the D.O. to the operator with in specified time to make the necessary corrective actions.

2.4 Export controls

The FSIS CSI and/or IIC ensure exported US meat and poultry products have passed the inspection by FSIS and comply with any additional requirements of the importing country. The operator completes signs and dates FSIS Form 9060-6 "application for export certificate". Upon receiving an application for export, the CSI reviews the application to verify that it is complete and also that the requirements of the receiving country have been met. The establishment's CSI verifies establishment and product eligibility in the export library published on the USDA's website before assigning an export certificate number to the lot. At the opening meeting, auditors were informed that the export library is an FSIS listing of export requirements that had been agreed between CFIA and FSIS.

The Meat, Poultry and Egg Product Inspection Directory is a listing of all US establishments that produce meat, poultry, and/or egg products regulated by USDA's FSIS for the domestic market and/or for exportation. This directory of establishments is updated monthly.

As part of the export verification task, the inspector conducts an on-site inspection of the product to be exported, verifies the presence and apposition of the official mark of inspection, the integrity of the packaging material, and signs and dates the application before providing the applicant with an unsigned export certificate to complete. Sometimes, the I-establishments are located at the same location as V establishments used to export products. In these situations, activities of verification of importation (I) and activities of verification under the grant of V establishments such as exportation, re-packaging, relabelling can be performed in the same building. However, separate inspectors, separate tasks and separate offices are assigned to the establishment type I and V.

It was confirmed during the audit that the U.S. export certificate contains only the information of the last exporting and/or processing establishment. No information is available on the slaughter house and the chain of processing establishments where the meat and meat products were produced. This fact leads to a lack of information regarding the source of the meat (slaughterhouse, country of origin). It can cause difficulty to verify information about animal health status and food safety status of the products. These facts are essential to verify the export eligibility of the products and when situation of recalls and investigation is triggered in case of fraud are present. As described in the MOP chapter 11.2.5.1, the name, address and registration number of the slaughter, processing establishment and the consignee are described in the Canadian export certificate.

After the verification of the application and the product, the unsigned certificates are provided to the operator one at a time and kept under locked with records at the FSIS office. The FSIS inspector keeps control of the official stamp or can give a pre-stamp authorization to the operator when a printer is used to produce larger number of stickers with the official inspection mark. In case of non-compliance situation, the operator may lose the pre-stamp authorization provided by the FSIS. Unused stickers are destroyed by the inspector.

Effective February 1, 2017, Canada no longer requires a veterinarian to sign FSIS forms 9135-3 and 9135-3A, but veterinarian signature is required for all letterhead certificates accompanying the products and when the animal health attestations are added to the "remarks" section of FSIS forms 9135-3 and/or 9135-3A.

When export certification services are performed in an official establishment (M and P establishments), the issuance of export certificates required by 9 CFR part 322 and 381.104 through 381.111 are not reimbursable services. In the V establishments, any certification and signature of certificates that is in addition to the FSIS regulatory requirements as described in 9 CFR 322.3 are considered reimbursable services. Per example, additional certification required by the importing country and the transferring of products for export is considered as reimbursable services.

Establishments eligible to export product to Canada are required to stun poultry prior to slaughter as per Canada's country requirements found in the export library. As indicated in FSIS Directive 9000.1, inspection personnel must verify country requirements as posted in the FSIS export library prior to certifying products on the export certificates (FSIS form 9135-3 for Canada). As per the export library, FSIS is required to certify that birds were subjected to humane slaughter and were effectively stunned before slaughter. During the audit of a poultry slaughter establishment, it was explained that monitoring of appropriate poultry stunning was performed by the operator via their good commercial practices (GCP). It was understood via interview that FSIS verifies the operators' monitoring of this Canadian import requirement through their regular poultry GCP verification task. As described in FSIS directive 6100.3, FSIS verifies stunning procedures during the GCP task and findings are documented in the PHIS.

The letter of attestation regarding the monitoring of the effectiveness of the poultry stunning is issued annually by the slaughterhouse operator. The attestation is provided to the U.S. establishment responsible for the export of the poultry meat when it is not the producing establishment. Prior to signing the export certificate, FSIS inspectors rely on the letter of attestation for stunning shared between the operators to ensure that Canadian import requirements are met. The letter of attestation was not corroborated by the FSIS inspection personnel in contrast to the Canadian export verification procedure explained in the Canadian meat hygiene manual of procedures (11.2.4.2).

No clear definition of "processing" is available in the 9 CFR 301.2 only the term prepared as defined as slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed. As specified in 9 CFR 327.18 all products, after entry into the United States, shall be deemed and treated as domestic products.

2.5 Grant of inspection

An applicant can request a grant of inspection by sending an application to the D.O. Different application forms are completed for official M, P and I establishments and voluntary inspection facility establishments (V). The D.O. processes the application and the district managers (DM) decide that inspection service should be provided to the establishment.

16 different categories of V establishments are identified in 9 CFR 362.2. To register as a V-establishment, the operator must first apply to FSIS for voluntary reimbursable inspection services. The applicant must meet the general requirements of the regulatory requirements under the Federal Meat Inspection Act and Poultry Products Inspection Act 9 CFR, Chapter III, 416.1 to 416.6. The DM instructs a designee to visit the facility to determine whether it meets the general requirements for the service requested.

Only certification, identification and food inspection services at V establishments were observed during the audit. The V establishments perform voluntary inspection services for the certification of export. Furthermore, the V establishments with identification service (meat and poultry) perform activities of division of the meat and poultry product into smaller portions, its combination into larger units, or its repackaging and relabelling. In these Identification establishments, the regulations do not permit any product reconditioning, "ice glazing," or other types of further processing operations, such as cutting, boning, or trimming, which must take place at official establishments (M or P). Processing of certain food articles not covered by the FMIA or PPIA is permitted in establishments under USDA inspection as a reimbursable service (V establishments).

USDA has set a rule that any food product containing the following is not subject to the FMIA or PPIA and to FSIS inspection: (1) 3 % or less raw meat or less than 2 % cooked meat, or (2) less than 2 % cooked poultry meat, less than 10 % of cooked poultry skins, giblets, or fat, separately, and less than 10 % of cooked poultry skins, giblets, fat, and meat in combination, or specific condition provided the poultry ingredients were prepared under domestic or foreign inspection and the product is not represented as a poultry product.

3 Ante-mortem, humane handling and animal welfare controls

3.1 Ante-mortem inspection, humane handling and animal welfare (poultry)

3.1.1 Ante-mortem

It was observed that the definition of lot is determined by the operator not FSIS. In the establishments visited, the definition of lot varied from being poultry per grower to poultry processed in 1 shift. Therefore, a lot could include more than one truck load, or farm(s). The auditors observed the IIC or the CSI performing ante-mortem a few times a day within the framework of the task poultry GCP verification task. As described in 9 CFR 381.70, an ante mortem inspection of poultry shall be made of poultry on the day of slaughter in any official establishment. Although the FSIS training module on ante-mortem inspection of poultry requires the trainee to perform ante-mortem inspection on a lot basis, US regulations seem to be flexible and require ante-mortem to be performed on the day of slaughter "where and to the extent considered necessary by the administrator" as described in 9 CFR 381.70.

As per the meat inspection regulations "ante-mortem examination" means, in respect of a food animal that is slaughtered at a registered establishment, the examination of the animal, or the examination of a sample from a shipment of animals that includes the food animal, and the examination of the animal information document in respect of the animal or the shipment of animals, by the operator under the supervision of an official veterinarian. Advanced copies of flock sheets for each scheduled lot are reviewed by the operator. The flock sheets contain information on the health of the flock, medication withdrawal, extra-label usage of medications or food additives, and percentage of mortality and disease. The verification of flock sheet by the FSIS is not a requirement as per 9 CFR part 381 and FSIS directive 6100.3 ante mortem and post mortem poultry inspection.

3.1.2 Dead on arrival (DOA)

The auditors observed the FSIS inspection personnel performing the poultry good commercial practices inspection task which included the verification of the operator's animal welfare program. The FSIS GCP verification task did not include the direct observation of the truck and the crates maintenance, however the operator poultry GCP program contains clear instructions, monitoring and training procedures about humane handling, crates, and extreme climate temperatures to prevent DOAs. This was consistent finding across the three establishments audited. The operator provided the total number of DOA to FSIS on the following day to add the DOA number to the condemnation certificate. The DOAs were identified, counted, and weighed, and the number was reported on FSIS form 9061-2, poultry condemnation certificate.

If a consistently large amount of DOA was observed by the FSIS, the non-compliance was documented in a weekly MOI. If the non-compliance is egregious (any act or conditions that results in severe harm to animals), an NR is issued and the operator has to put in place immediate correctives actions. The repetitive linked NR can be escalated to the FLS and the D.O. for enforcement actions. An LOC can be issued by the D.O. when GCP and DOA in poultry establishment are found to be non-compliant. If the situation stays non-compliant without any correctives actions, the grant (licence to operate) of the establishment can be revoked. No such situation was observed in poultry establishments audited.

The auditors were informed during the interview that the humane handling at the farm and during the transport is under the jurisdiction of the animal and plant health inspection services (APHIS).

3.1.3 Stunning

The auditors were informed that there is no regulation requiring that poultry be stunned prior to bleeding in US establishments. However, CFR 381.65(b) states that poultry shall be slaughtered in accordance with good commercial practices in a manner that will result in thorough bleeding of the carcasses and assure that breathing has stopped prior to scalding. Regulatory actions for noncompliance with 9 CFR 381.65(b) include noncompliance records and potentially stopping the poultry line with a regulatory control action by inspection personnel.

The audit team observed the verification of the effectiveness of the stunning as part of the operator animal welfare program. In one of the slaughterhouse visited, halal slaughter was preceded by electrical stunning. The operator GCP program included training, clear instructions regarding when a corrective action has to be implemented and monitoring records with a prescribed frequency. The FSIS inspection personnel verified the effectiveness of stunning in the poultry GCP task. As a part of this task, the inspection personnel must ensure that stunning equipment is functioning properly.

In the case of non-compliance related to stunning, the FSIS stops the line, adds the non-compliance to MOI, but an NR is not issued because it is not mandatory as per the regulations. If the establishment is mistreating the birds, but the birds are still be fully bled and are not breathing when they enter the scalder, the PHV, IIC, or designee is to discuss the mistreatment with the establishment management, document the discussion and any planned actions on the part of the establishment in a memorandum of interview (MOI); and provide copies of the MOI to the establishment, the DVMS, and the inspection file. The DVMS is to review the MOI and determine whether the establishment's mistreatment requires notification of the appropriate state officials. Verification of appropriate stunning is not included in the U.S. regulations; however, as per 9 CFR 381.65(b), FSIS must verify that poultry has stopped breathing prior to scalding. The auditors were informed by FSIS inspection personnel that if the stunning is not proper, there would be more cadavers (As per FSIS directive 6100.3, cadavers are poultry that die from causes other than slaughter or are not physiologically dead because of ineffective slaughter before they enter the scald vat and drown) observed at the evisceration floor, which would be an indicator to go to the ante-mortem and look to see if the birds are entering the scalder tank alive, in which case, an NR would be issued.

3.1.4 Bruising

At 3 poultry establishments audited, the operator implemented animal welfare program which contains monitoring of bruising (legs-wings) with maximum limits. These GCP programs are verified by the FSIS via their poultry GCP verification task. If there is minor non-compliance not rising to the level of non-compliance, it is discussed with the operator in weekly meeting and documented in the MOI. In observed repeated minor non-compliances or a major non-compliance rise to the level of a regulatory non-compliance, it must be documented in a NR. The FSIS verification of bruising is carried out in accordance with FSIS directive 6100.3 and 9 CFR 381.89.

3.2 Ante-mortem inspection, humane handling and animal welfare (beef and pork)

The audit demonstrated that the FSIS verification of the animal welfare at the ante-mortem is completed via the humane activities tracking system (HATS). The HATS include 9 categories of daily tasks listed in the PHIS task calendar. These tasks are performed by FSIS inspector with appropriate training. The task results are recorded in the PHIS. The operator has to implement the humane handling animal welfare program as per the FSIS Compliance Guide for systemic approach to the humane handling of livestock. The operator can choose between the systemic approach and the robust systemic approach. In contrast to systemic approach, the robust systemic approach includes additional features such as written procedures, written reports and training program. These documents are available to FSIS for review. All beef and pork slaughter plants audited had a robust systemic approach program. The HATS activity doesn't include verification of truck condition or investigation conducted by FSIS in case of DOAs. The truck condition maintenance is part of the operator systemic approach because once a vehicle has entered an official slaughter establishment's premises, it is considered to be part of that establishment's premises as reported in the FSIS directive 6900.1.

The cadavers of swine that die at the barn or during transport (DOAs) are not required to be seen by FSIS. The operator can dispose of obvious condemnable conditions (for example, moribund) at ante-mortem without the FSIS' presence and oversight, whereas in beef, the cadaver is verified by FSIS veterinarian. According to the APHIS bovine spongiform encephalopathy (BSE) plan, cattle 30 months or older condemned at ante-mortem inspection, and cattle of any age condemned for nervous signs or rabies are sampled by FSIS employee or designated off-site sample collection facilities.

All establishments have a US detain pen where the ante-mortem inspection of suspect animals was performed by a veterinarian and observations were recorded in the ante-mortem form. Identification of suspect animals was completed either by affixing a metallic tag in the ear (before the stunning) or in the tongue (after stunning). These tags with a unique number were kept locked as accountable items by the FSIS in the ante-mortem area. No loss of identification of suspect animal between the ante-mortem and the post-mortem station was observed during the audit.

The audit team observed that non-ambulatory and crippled animals were segregated and moved in U.S. suspect pen or in the slow pig's pen (hogs with stress syndrome). As per 9 CFR 313.2, dragging is not permitted. In the 3 establishments audited, non-ambulatory hogs (hogs not willing or able to walk) were physically moved without being stunned first with a bobcat and loaders to a pre-slaughter assembly area and kept there until moved again and stunned, bled and shackled. The equipment used for this purpose was a bobcat, some with retractable floor or a cage. The use of a bobcat to move the hogs with stress syndrome were observed to have contributed to an increase of distinct signs of stress such as laboured breathing, patching skin discoloration, generalized trembling/muscle tremors, and vocalisation. As per MIR 62(1), No food animal shall be handled in a manner that subjects the animal to avoidable distress or avoidable pain 

In the beef slaughter establishments, non-ambulatory cattle were stunned on site without being moved, which was consistent with 9 CFR 313.2. The beef slaughterhouse with halal ritual slaughter stunned the animals before the slaughter. The FSIS verification of effectiveness of stunning was done via the HATS activities on a daily basis and was observed during the audit.

4 Post-mortem controls

4.1 Post-mortem inspection (poultry)

2 of the 3 establishments audited were operating under the new poultry inspection system (NPIS). NPIS is an inspection system which is in addition to streamlined inspection system (SIS), new line speed inspection system (NELS), new turkey inspection system (NTIS) or traditional inspection already in place at the establishments. NPIS is voluntary and can function under the SIP (salmonella initiative program) waiver, where daily pathogen testing is required to demonstrate that the waiver provides a demonstrated improvement. Waivers are granted by FSIS to the operator to increase line speed over 140 carcasses/ minute and/or to change the chilling time of the carcasses if the facility is able to demonstrate and maintain bacteriological outcomes (SIP) at compliant levels. On a monthly basis, the operator sends bacteriological results to FSIS electronically. In the NPIS establishments, the waiver was reviewed and the establishments presented the compliance bacteriological controls, samplings and results (SIP). The salmonella replaced post-chill generic E. coli testing requirements. The salmonella testing is a part of the criteria used by FSIS to grant a waiver to the establishment. If the establishment demonstrates control of their process with salmonella testing, a waiver can be granted to establishment to increase the speed of the slaughter line or modify the chilling period.

Under NPIS, each evisceration line has 2 inspectors: one on-line and one off-line. The on-line carcass inspector (CI) conducts continuous carcass-by-carcass inspection and the off-line verification inspector (VI) conducts food safety verification inspection activities. Establishments are responsible to sort and remove unacceptable carcasses and parts before presentation to CI stationed at end of the line. Offline reprocessed carcasses are returned to the line before the IIC and all salvage parts are set apart and inspected by the FSIS. In the traditional poultry inspection system, all the inspection of the carcass and parts is done by on-line inspectors (IPP) and the off-line activities are conducted by the CSI. FSIS performs therefore all the post-mortem inspection and disposition.

Both systems of poultry inspection perform zero-tolerance task which verifies the absence of fecal contamination. The FSIS and operator CCP zero-tolerance station can be situated before or after the CI station in NPIS. NPIS establishments have to meet and perform testing for ready to cook (RTC) standards while the traditional, SIS and NELS have to meet the poultry finished products standards which were reviewed and audited during this audit. FSIS inspection personnel perform a RTC verification task as described in the FSIS directive 6500.1. A zero tolerance for fecal contamination is implemented as the 9 CFR 381.65(e) states: poultry carcasses contaminated with visible fecal material shall be prevented from entering the chilling tank. Zero tolerance for fecal contamination is applicable for carcasses and parts. 9 CFR 381.65(f) does not apply to ingesta. However, inspection program personnel who find ingesta during fecal contamination checks should notify establishment management to remove ingesta from affected carcasses. As per the final rule, the performance standard for OCP–3, digestive content (ingesta), is 18.6%.

In NPIS establishments, it was found that no correlation tests were performed by FSIS and the operator to verify the performance of the sorters. The sorters are evaluated after initial training and annually thereafter. The auditors also observed the absence of presentation standards. In the NPIS, the operator has a CCP zero tolerance for septicemic/toxemic carcasses and parts. The FSIS conducts a test on 10 carcasses before the CI station every hour to look for zero tolerance defects (septicemia-toxemia and fecal contamination).

The IPP verifies compliance with 9 CFR 381.65(e) by determining whether the establishment's sanitary dressing and process control procedures are adequate to ensure that carcasses entering the chiller are not contaminated with fecal material. Should the operator`s CCP for zero tolerance fails, the correctives actions and preventative actions should be implemented as per the decision tree. If the FSIS zero tolerance fails, the FSIS inspection personnel will issue a NR and the operator will need to implement corrective and preventive actions.

NPIS poultry slaughter establishments are allowed to use 1) approved online reprocessing (OLR) antimicrobial intervention system or 2) offline reprocessing (OFLR) antimicrobial substance including chlorinated water containing 20 ppm to 50 ppm available chlorine or 20-200 ppm of peroxy-acetic acid. The term re-conditioning is used only for the products on the floor. The establishment uses chlorinated water to wash products that are contaminated (for example, products that fell on the floor). As per Canadian requirements, all visible contamination shall be removed by washing and/or trimming in an efficient yet sanitary fashion. Corrective action to prevent a recurrence, if required should be incorporated as quickly as possible and as to be part of HACCP.

4.2 Post-mortem inspection (pork)

3 swine slaughter establishments were audited. 1 establishment operates under HIMP and 2 under the traditional inspection system. In the traditional inspection system, on-line inspectors are responsible for the inspection of the carcasses, parts and viscera. In HIMP, the inspection personnel perform:

• system inspection that involves the evaluation of in-plant inspection findings and determining the effectiveness of the overall design and execution of all establishment slaughter processes under the HACCP and process control plans
• carcass inspection including the examination of each carcass and its parts to determine that they are unadulterated
• verification inspection involving the evaluation of the effectiveness of the establishment's HACCP and process control in meeting the relevant performance standards

In the HIMP plant, the carcasses and parts passed through different post-mortem inspection procedures and stations. The carcasses and parts passed through the operator detectors and these detectors railed out the abnormal carcasses and parts towards the FSIS inspection stations. The abnormal parts are then sent to an inspection station managed by the operator. The FSIS veterinarian inspects the carcasses identified at ante-mortem or the carcasses identified by the operator detectors. The following stations are located at the HIMP plant:

• # 1: operator detectors head, viscera and head stations
• # 2: FSIS head inspection station
• # 3: FSIS viscera inspection station
• # 4: zero tolerance station
• # 5: FSIS carcass inspection station

The FSIS inspection at the head, viscera and carcass stations was performed by the on-line IPP, thereby allowing the inspection of 100 % carcasses and parts. The inspection at the zero tolerance station was performed by the off-line CSI and was done as per the frequency provided by the PHIS. The zero tolerance station was used by the FSIS to perform the daily task and by the operator to perform the CCP task. If contamination was present at the zero tolerance station during FSIS verification or the operator CCP, the carcasses were trimmed and returned to the main evisceration line to be inspected at the FSIS carcass inspection station.

In the traditional pork slaughterhouses visited during this audit, the carcasses and parts passed through different post-mortem inspection procedures and stations depending on the design of the evisceration line. FSIS on-line IPP was responsible for the head, viscera and the carcass inspection. The zero tolerance station was used by the FSIS to perform the daily task and by the operator to perform the CCP task. In the situation where zero tolerance station was located before the FSIS carcass station inspection station, if the task or the CCP failed, the trimmed carcasses were re-verified by the FSIS at the carcass inspection station. When the zero tolerance station was located after the FSIS carcass inspection station, the contaminated carcasses were trimmed but not railed in to be re-inspected by the FSIS IPP. In this situation, the operator was responsible to release the contaminated carcasses after the contaminant was removed. In these situations, FSIS was notified by the operator of these deviations during record review and FSIS was not responsible to release these carcasses.

4.3 Post-mortem inspection (beef)

In beef plants audited, the carcasses and parts passed through different post-mortem inspection procedures and stations. The inspection at the head, viscera and carcass inspection stations was performed by the online IPP. Furthermore, final carcass by carcass inspection was also completed by online IPP, thereby allowing the inspection of 100% of the carcasses. All 3 beef establishments had a rail out after carcass by carcass inspection station, which was used to re-orient the contaminated carcasses after trimming to be re-inspected by FSIS.

The zero tolerance station was situated just before the final wash. This station was used by the FSIS to perform the daily task and by the operator to perform the CCP. At 2 (out of 3) beef establishments visited during this audit, if the task or CCP failed, there was no rail-out/rail-in to redirect the trimmed carcasses for FSIS inspection at the carcass by carcass inspection station. In this situation, the operator was responsible to release the contaminated carcasses after the contaminant was removed. FSIS was notified of these deviations during record review and was not responsible to release these carcasses.

4.4 Specified risk materials controls

At the 3 bovine slaughter establishments audited, specified risk materials (SRM) controls were implemented as per regulatory requirements. SRM was treated as inedible and prohibited for use as human food. They were removed from the carcasses of cattle, segregated from edible materials, and disposed of in accordance with CFR 9 314.1 and 314.3.

FSIS requirements in 9 CFR 318.24 prohibit the use of SRM vertebral bones in the production of beef advanced meat recovery (AMR). The establishments audited had AMR equipment controls in place which efficiently prevented the use of OTM bovine columns for AMR. The removal of the DRG (dorsal root ganglia) by hand boning procedures was implemented as intended in all 3 establishments.

The verification of SRM controls in beef slaughter establishments is performed by the CSI and the IIC. The inspection task includes the verification of the procedures for the removal, segregation, and disposition of SRMs, and requires the inspection personnel to review the operator's procedures and records incorporated in their SSOP. Also, CSI verified that the final product after deboning is free of any SRM at the end of the deboning table and at the packaging area. The removal, segregation, and disposition of SRM and DRG observed at the establishments are compliant with the 9 CFR 310.22(e) and the FSIS verification tasks followed the directive 6100.4.The FSIS inspection oversight of SRM controls in processing establishments includes on-site verification of mechanically separated beef production controls to prevent the use of OTM carcasses and ensuring that the SRM portion of the vertebral columns is removed in a manner that prevents edible product contamination.

5 HACCP plan and pre-requisite programs

HACCP, pre-requisite programs and/or SOP were audited in the M, P and V establishments. In the M and P establishments, the operator must have and implement a HACCP plan and FSIS verify the implementation via HACCP verification task. V establishments may choose to have a sanitation SOP or HACCP, but are not required to do so. Similarly, the inspection program personnel are not required to perform SSOP or HACCP verification activities listed in Directive 5000.1 revision 2 in these establishments. However, IPP verifies compliance with the requirements of 9 CFR 416.1 - 416.6 or Part 592 (for egg products) at all facilities requesting reimbursable services. The V establishments may conduct more than one type of activities under voluntary inspection services and may be situated at the same location as the official I, M and P establishments. As per the Canadian requirements (MIR 30.1 (1)), the operator of an establishment shall develop, implement and maintain the required prerequisite programs, HACCP plans and other control programs as set out in the food safety enhancement manual (FSEP) and the meat hygiene manual of procedures.

The FSIS oversight of the establishment's HACCP risk evaluation was audited on site. The flow diagrams (a systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item) were audited and it was observed that the food safety hazard (any biological, chemical, or physical property that may cause a food to be unsafe for human consumption) were not identified on the flow diagrams but were identified on the CCP descriptive form. Furthermore, it was observed that establishments were not required to develop plant schematic as per 9 CFR 417. A plant schematic include the flows of raw products, ingredients and finished products, the flows of packaging materials, the employee traffic pattern throughout the establishment including change rooms, washrooms and lunchrooms and the flows of the waste, inedible products, chemicals, and other non-food products. In Canada, plant schematic is part of HACCP plan as required by CFIA's FSEP Manual. It provides a basis for evaluating potential areas of cross-contamination by pathogens, foreign materials, chemicals or allergens. Overall, it was concluded that differences in implementation of HACCP exist between Canada and the USA, however, both systems results in similar outcome to ensure that food is safe for human consumption.

In the current environment where food safety systems and their controls provide flexibility for establishment to implement their own procedures and critical limits, the validation process for these measures a significant importance. The auditors were informed the operators are responsible for the validation of these control measures. The Codex Alimentarius definition of validation is obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. As well, in the Canadian FSEP manual, every establishment shall demonstrate that the critical control points are capable, on a consistent basis, of achieving the intended level of hazard control. Validation is performed at the time the CCP is designed, or when changes indicate the need for re-validation. Validation of a CCP is, whenever possible, performed before it is fully implemented. This validation has to be supported by scientific, technical or regulatory support, commissioned testing data and supporting data.

As per CFR 417.4, every establishment shall validate the HACCP plan's adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented. Furthermore, IPP verifies the validation by conducting hazard analysis verification (HAV) task. As per HAV verification task, validation is composed of two parts or elements: (1) scientific and technical support and (2) initial in-plant demonstration proving the HACCP system can perform as expected.

5.1 EV program

FSIS and the agricultural marketing service (AMS) have designed an export verification (EV) program for RTE closed face sandwiches that are produced under the voluntary inspection reimbursable services and intended for export to Canada. The program and a list of eligible establishments are available on the AMS website. The auditors were informed the EV program will be implemented on February 13, 2017, as outlined in FSIS notice 98-16. The program includes the following:

• registration of all establishments under the voluntary inspection reimbursable services producing closed-face sandwiches intended for export to Canada
• all establishments under the EV program must implement a HACCP plan;
• FSIS will be conducting daily inspections, which will include inspection oversight of HACCP and SOP controls
• AMS will conduct a microbiological testing program, for Listeria and Salmonella, on behalf of FSIS, to verify the adequacy of establishment's food safety system in producing these products

9 establishments producing and exporting closed face sandwiches are currently listed. FSIS will perform AMS – fully cooked-not shelf stable HACCP task twice per week. AMS will conduct a microbiological testing program on behalf of FSIS; the program will include 2 types of testing (routine and intensified) to ensure that participating establishments are controlling Listeria monocytogenes and Salmonella. The EV program was in the process of being implemented at the time of the audit. Therefore, auditors were unable to complete the evaluation of the implementation of the AMS program.

6 Processing controls

6.1 Salmonella control in RTE meat products

As described in the FSIS Salmonella compliance guidelines for meat and poultry, establishments producing dry, fermented, and salt cured products may also implement a process achieving a 5D-log lethality of Salmonella for meat products and a 7D-log lethality of Salmonella for poultry products. Regardless of the lethality process used, all establishments that produce RTE meat and poultry products must provide supporting documentation that the process for their RTE products achieves the required or recommended reduction of Salmonella. This supporting documentation must be provided as part of an establishment's hazard analysis decision-making documents, and validation data must be included in its HACCP records (9 CFR 417.5(a)(1) and (2) and 417.4(a)).

As described in MOP chapter 11.7.3.2.2.2 (U.S. import requirements), it is required that RTE non-heated products, such as dry cured salted and dry cured fermented meat and poultry products that are processed without the application of heat require a 5D log reduction of Salmonella in meat products and a 7D log reduction of Salmonella in poultry products because of the synergistic antimicrobial effect of lower pH and/or lower water activity. The validation may be done through the combination of scientific peer reviewed journal articles which includes critical operational parameters that align with the establishment's process/product composition or challenges study/inoculated pack. The scientific supporting documentation should be sufficiently related to the establishment's product and process.

During CFIA audit conducted in 2013, the auditors learned during on-site activities that USDA-FSIS allows establishments to produce the above types of products without having to conduct a validation of the lethality of the process for the required 5D log Salmonella reduction (non-heat treated RTE beef products)/ 7D log Salmonella reduction (non-heat treated RTE poultry products). The same observation was made regarding the validation of Salmonella control requirements during CFIA audit conducted in 2017. The scientific article was used for validation; however establishment was not able to prove that the variables in the study represent the conditions of their process.

6.2 Allergens

Multiple inspection tasks are conducted to verify that an establishment's food safety system meets regulatory requirements with regard to allergens and other ingredients of public health concern, including the HAV task, the HACCP verification tasks, the review of establishment data task, preoperational and operational SSOP tasks, the general labelling task, and the big 8 formulation verification task. If non-compliance is detected, a recall can be initiated as described in the FSIS directive 8080.1.

As described in the FSIS directive 7230.1, the allergens include wheat, crustacean shellfish, eggs, fish, peanuts, milk, tree nuts and soybeans. The ingredients of public health concern that may cause food intolerance include sulfites, lactose, tartrazine, gluten, and monosodium glutamate (MSG); yet they are not considered allergens. Canada's priority food allergen includes US's big 8; and sesame and mustard. As per the export library requirements for Canada, descriptive terms applied to meat and poultry product must be consistent with Canadian Food and Drug Regulations and the Canadian MIR which includes allergens declaration.

7 Closing meeting

The closing meeting was held in Washington on February 10^th, 2017 with USDA-FSIS. At the meeting, a summary of the preliminary systemic findings from the audit were presented by the CFIA lead auditor.

8 Conclusions

Overall, the audit showed that food safety systems in the US are performing as intended in an adequate manner and generally demonstrate an acceptable implementation of controls for all areas described above. Based on the audit findings, this report contains recommendations with the intent of finding solutions for identified deficiencies.

9 Annex